Kristi Rosa

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.

A supplemental biologics license application has been submitted to the FDA to expand the current indication of the CAR T-cell therapy axicabtagene ciloleucel to include the second-line treatment of adult patients with relapsed/refractory large B-cell lymphoma.

Epcoritamab had a manageable toxicity profile when subcutaneously administered to patients with relapsed/refractory B-cell non-Hodgkin lymphoma and was found to elicit encouraging responses in those who were heavily pretreated.

The FDA has granted a priority review designation to a new drug application for lutetium-177-PSMA-617 for use in the treatment of patients with metastatic castration-resistant prostate cancer following androgen receptor pathway inhibition and taxane-based chemotherapy.

The FDA has granted a fast track designation to the first-in-class nucleotide analogue NUC-1031 for use as a potential therapeutic option in the frontline treatment of patients with advanced biliary tract cancer.

Health Canada has approved infigratinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring a FGFR2 fusion or other rearrangement.

The frontline triplet combination comprised of acalabrutinib, venetoclax, and obinutuzumab proved to be highly active and well tolerated when used in the treatment of patients with chronic lymphocytic leukemia.

The FDA has granted approval of a new indication for cetuximab plus encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by a FDA-approved test, after prior therapy.

The investigational next-generation ROS1/NTRK inhibitor taletrectinib was found to elicit encouraging responses with an acceptable toxicity profile in patients with ROS1-positive non–small cell lung cancer, according to preliminary data from the phase 2 TRUST trial.

The FDA has granted priority review to a supplemental biologics license application for the use of cemiplimab-rwlc in the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on, or after, chemotherapy.

The Japanese Ministry of Health, Labour, and Welfare has approved enfortumab vedotin for the treatment of patients with unresectable urothelial carcinoma that has progressed following chemotherapy.

The addition of pembrolizumab to best supportive care resulted in a statistically significant improvement in overall survival vs BSC alone in Asian patients with advanced hepatocellular carcinoma who previously received treatment with sorafenib, meeting the primary end point of the phase 3 KEYNOTE-394 trial.

The FDA has accepted the supplemental biologics license applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy in the frontline treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The addition of bevacizumab to erlotinib continued to provide a significant progression-free survival benefit over erlotinib alone when used in the frontline treatment of patients with EGFR-mutated, nonsquamous non–small cell lung cancer, according to data from the final analysis of the phase 3 BEVERLY trial.

The addition of TheraSphere™ Yttrium-90 Glass Microspheres to standard-of-care second-line chemotherapy in patients with colorectal cancer liver metastases led to a significant improvement in progression-free survival and hepatic PFS over chemotherapy alone, meeting both primary end points of the ongoing EPOCH trial.

The FDA has granted a fast track designation to the HER2-directed CAR macrophage CT-0508 for use as a potential therapeutic option in patients with solid tumors.

The FDA has authorized the marketing of Paige Prostate, an artificial intelligence–based software that was designed to help pathologists scan areas of the body for suspicious cancer as a supplement to the review of digitally-scanned slide images from prostate biopsies.

The FDA has approved ruxolitinib for the treatment of chronic graft-versus-host disease following failure of 1 or 2 lines of systemic therapy in adult and pediatric patients aged 12 years and older.

A rolling submission of a biologic license application to the FDA has been completed for betibeglogene autotemcel for use in adult, adolescent, and pediatric patients with beta-thalassemia who require regular red blood cell transfusions, across all genotypes.

Personalized medicine has come to the forefront of breast cancer management, with genomic tools being utilized to avoid unnecessary chemotherapy in those with early-stage disease, PARP and PI3K inhibitors improving outcomes for those who harbor select mutations, and the emergence of highly active targeted agents shaking up the HER2-positive paradigm.

The FDA has granted an accelerated approval to tisotumab vedotin for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The FDA has granted priority review to a biologics license application for the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients aged 12 years and older and weighing at least 40 kg who have unresectable or metastatic melanoma.

The addition of pembrolizumab to chemotherapy with or without bevacizumab significantly improved survival and response rates in patients with persistent, recurrent, or metastatic cervical cancer.

The addition of relatlimab to nivolumab prolonged benefit beyond initial treatment and first progression and reduced the risk of progression or death after the next line of systemic therapy vs nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.

COVID-19 continued to result in high admission and fatality rates among patients with chronic lymphocytic leukemia during the first 13 months of the pandemic, and although risk of severe infection was determined to be independent of age, CLL status, and treatment, being age 75 years or older was revealed to be a significant risk factor for death.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion of pembrolizumab plus chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

The FDA has approved cabozantinib for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed after prior VEGF-targeted therapy and who are radioactive iodine–refractory or ineligible.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the use of zanubrutinib in adult patients with Waldenström macroglobulinemia who have previously received at least 1 therapy or in the frontline treatment of patients who are not eligible for chemoimmunotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pralsetinib for use as a single agent in adult patients with RET fusion–positive advanced non–small cell lung cancer who did not receive prior RET inhibition.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab plus fluoropyrimidine and platinum-containing chemotherapy as frontline treatment for adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma with a PD-L1 combined positive score of 5 or higher.